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Cough and Runny Nose Childrens Plus Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide 160 mg/5mL; 1 mg/5mL; 5 mg/5mL Suspension — NDC 36800-0297-04 package photo

Cough and Runny Nose Childrens Plus Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide 160 mg/5mL; 1 mg/5mL; 5 mg/5mL Suspension

by TOP CARE (Topco Associates LLC) · 1 BOTTLE, PLASTIC in 1 BOX (36800-297-04) / 118 mL in 1 BOTTLE, PLASTIC
NDC 36800-0297-04
🏷️ FDA NDC (as labeled) 36800-297-04 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 36800-297-04
Product NDC 36800-297
11-digit billing NDC 36800029704
RxCUI 1086750
UNII 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH
UPC 0036800340619
Application # M012
SPL Set ID 6f04bd51-093c-4624-aef3-0145ac387386
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-12-31
Marketing end 2027-06-01
Route ORAL
Dosage form SUSPENSION
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 36800-297-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 36800-0297-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTOP CARE (Topco Associates LLC)
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedDec 2015
Product typeHuman Otc Drug
Portfolio35 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter oral suspension for children containing three active ingredients. Acetaminophen is commonly used to help relieve pain and reduce fever. Chlorpheniramine maleate is a first-generation antihistamine typically used to help reduce allergy symptoms and runny nose. Dextromethorphan hydrobromide is a cough suppressant commonly used to help reduce cough. This product is marketed under the FDA's over-the-counter monograph rules for cough, cold, and runny nose preparations.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Childrens Cold plus Cough plus Runny Nose 160 mg/5mL; 1 mg/5mL; 5 mg/5mL 00363-7920-04 WALGREENS 1 bottle — — FDA listed —
Cough and Runny Nose Childrens Plus 160 mg/5mL; 1 mg/5mL; 5 mg/5mLthis 36800-0297-04 TOP 1 bottle — — FDA listed —
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE 160 mg/5mL; 1 mg/5mL; 5 mg/5mL 50580-0245-01 Kenvue 1 bottle — — FDA listed —
Childrens Plus Cough and Runny Nose 160 mg/5mL; 1 mg/5mL; 5 mg/5mL 55910-0297-04 Dolgencorp, 1 bottle — — FDA listed —
CVS Childrens Cold plus Cough plus Runny Nose 160 mg/5mL; 1 mg/5mL; 5 mg/5mL 69842-0792-04 CVS 1 bottle — — FDA listed —
TOPCARE Childrens Cold and Cough and Runny Nose 1 mg/5mL; 5 mg/5mL; 160 mg/5mL 76162-0792-04 Topco 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
Dec 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
36800-0297-04 You're viewing this 1 BOTTLE, PLASTIC in 1 BOX (36800-297-04) / 118 mL in 1 BOTTLE, PLASTIC 2015-12-31 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 36800-297-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 36800-0297-04, written without dashes as 36800029704. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 36800-0297-04, the first segment (36800) is the labeler code FDA assigned to TOP CARE (Topco Associates LLC); the middle segment (0297) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but TOP CARE (Topco Associates LLC) has reported a marketing end date of 2027-06-01, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
TOP CARE (Topco Associates LLC) is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 22 words ▾

Uses temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache temporarily reduces fever

⏱️ Dosage and Administration 102 words ▾

Directions this product does not contain directions or complete warnings for adult use. mL = milliliter shake well before using do not give more than 5 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose; otherwise, use age Weight (lb) Age (yr) Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses (10 mL each) in 24 hours, which is the maximum daily amount with other drugs contaning acetaminophen Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. with any other drug containing acetaminophen (prescription or non-prescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if the child has liver disease glaucoma a breathing problem such as chronic bronchitis cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers the blood thinning drug warfarin When using this product do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if new symptoms occur redness or swelling is present pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.

Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Quick medical attention is critical for adult as well as children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 17 words ▾

Active ingredients (in each 5 mL) Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients acesulfame potassium, alcohol, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose purified water, sodium benzoate, sorbitol, xanthan gum

🎯 Purpose 7 words ▾

Purposes Pain reliever/fever reducer Antihistamine Cough suppressant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 36800-0295-74 · Topco 36800-0298-04 · TOPCARE →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.